FHIR IG analytics| Package | hl7.fhir.uv.clinical-study-protocol |
| Resource Type | ImplementationGuide |
| Id | ImplementationGuide-hl7.fhir.uv.clinical-study-protocol.json |
| FHIR Version | R6 |
| Source | https://build.fhir.org/ig/HL7/vulcan-udp-ig/index.html |
| URL | http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol |
| Version | 1.0.1-ballot2 |
| Status | draft |
| Date | 2026-02-10T16:49:31+00:00 |
| Name | ClincalStudyProtocol |
| Title | Clinical Study Protocol (Vulcan UDP) |
| Realm | uv |
| Authority | hl7 |
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Note: links and images are rebased to the (stated) source
Generated Narrative: ImplementationGuide hl7.fhir.uv.clinical-study-protocol
Language: en
The official URL for this implementation guide is:
http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol
FHIR
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"text": {
"status": "generated",
"div": "<!-- snip (see above) -->"
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"valueCode": "trial-use"
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"version": "1.0.1-ballot2",
"name": "ClincalStudyProtocol",
"title": "Clinical Study Protocol (Vulcan UDP)",
"status": "draft",
"date": "2026-02-10T16:49:31+00:00",
"publisher": "HL7 International / Biomedical Research and Regulation",
"contact": [
{
"name": "HL7 International / Biomedical Research and Regulation",
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"value": "http://www.hl7.org/Special/committees/rcrim"
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"value": "UDP@HL7Vulcan.org"
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]
}
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],
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"license": "CC0-1.0",
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"packageId": "hl7.fhir.uv.extensions",
"version": "dev"
},
{
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"uri": "http://terminology.hl7.org/ImplementationGuide/hl7.terminology",
"packageId": "hl7.terminology",
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],
"definition": {
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"grouping": [
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"name": "Profiles & Extensions: Narrative Structures",
"description": "Profiles and Extensions to allow representation of narrative structures"
},
{
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"name": "Profiles & Extensions: Protocol amendment",
"description": "Profiles and Extensions representing amendments to a protocol"
},
{
"id": "GroupOTH",
"name": "Profiles & Extensions: Other",
"description": "Other Profiles and Extensions"
},
{
"id": "GroupCS",
"name": "Terminology: Code Systems",
"description": "The majority of required code systems are maintained by CDISC on the NCI Thesaurus"
},
{
"id": "GroupVS",
"name": "Terminology: Value Sets",
"description": "These define sets of codes used by systems conforming to this implementation guide. (NOTE ICH and CDISC have signed a Memorandum of Understanding (MOU) collaborating to support the maintenance and governance of ICH M11 controlled terminology...focusing on the use of CDISC’s unified governance process and terminology services for long-term support.)"
},
{
"id": "GroupJPN",
"name": "Example Instances: Japanese Protocol",
"description": "These examples show how the same content can be represented in both English and Japanese. See the [Downloads section](downloads.html) for a file to load the instance set to a server."
},
{
"id": "GroupIGBJ",
"name": "Example Instances: IGBJ",
"description": "Example Protocol - IGBJ - English"
},
{
"id": "GroupELIG",
"name": "Example Instances: Eligibility Criteria",
"description": "Structured Representation of Eligbility Criteria"
}
],
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"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/m11-research-study-narratives"
},
"name": "Research Study Narratives",
"description": "Narrative elements associated with a research study following the ICH M11 CeSHarP template.\nThe ICH M11 CeSHarP template for a study protocol specifies the headings to be used to organize protocol content.\nFor a FHIR representation of the protocol to be compliant with this template each of the narrative sections must \nbe organized using these headings. Only if there is material that does not properly belong under one of the M11 \nheadings can additional codes be created.",
"isExample": false,
"groupingId": "GroupNAR"
},
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"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/m11-research-study-profile"
},
"name": "M11 Research Study",
"description": "Constraint of ResearchStudy to M11 Guidance\nAn instance of this profile represents a single version of the protocol definition. Previous amendments are represented\nby further instances of ResearchStudy linked through the relatedArtifact attribute.",
"isExample": false,
"groupingId": "GroupNAR"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
}
],
"reference": {
"reference": "StructureDefinition/narrative-elements"
},
"name": "Narrative Elements",
"description": "Narrative content for the ResearchStudy.",
"isExample": false,
"groupingId": "GroupNAR"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
}
],
"reference": {
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},
"name": "M11_ProtocolAmendment",
"description": "Amendment to a protocol. This is originally from EBM.",
"isExample": false,
"groupingId": "GroupAMD"
},
{
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{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
}
],
"reference": {
"reference": "StructureDefinition/m11-amendment-detail"
},
"name": "M11_AmendmentDetails",
"description": "Provides detail of a single amendment - repeats within the overal amendment report",
"isExample": false,
"groupingId": "GroupAMD"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
}
],
"reference": {
"reference": "StructureDefinition/m11-amendment-scope-impact"
},
"name": "M11_AmendmentScopeImpact",
"description": "Provides number or percentage of each group affected by a single amendment",
"isExample": false,
"groupingId": "GroupAMD"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
}
],
"reference": {
"reference": "StructureDefinition/m11-confidentiality-statement"
},
"name": "M11_ConfidentialityStatement",
"description": "Sponsor Confidentiality Statement. This is a replica of EBM ResearchStudySponsorConfidentialityStatewent",
"isExample": false,
"groupingId": "GroupOTH"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
}
],
"reference": {
"reference": "CodeSystem/narrative-elements-cs"
},
"name": "Narrative Elements Code System",
"description": "Composition Types to Manage Protocol Narrative Elements",
"isExample": false,
"groupingId": "GroupCS"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/m11-study-amendment-reason-vs"
},
"name": "Study Amendment Reason Value Set",
"description": "Codes drawn from NCI Thesaurus to represent the reasons a study was amended.",
"isExample": false,
"groupingId": "GroupVS"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/ddf-study-title-type-vs"
},
"name": "CDISC DDF Study Title Type Value Set",
"description": "Codes drawn from NCI Thesaurus value set $NCIT#C207419 CDISC DDF Study Title Type Value Set Terminology\nThese codes represent the types of title or name a study can have according to CDISC DDF",
"isExample": false,
"groupingId": "GroupVS"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/cdisc-yes-no-vs"
},
"name": "CDISC Yes No Unknown Not Applicable Value Set",
"description": "Contains all values from C66742 - CDISC SDTM Yes No Unknown or Not Applicable Response Terminology",
"isExample": false,
"groupingId": "GroupVS"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/m11-identifier-type-vs"
},
"name": "M11 Identifier Type Value Set",
"description": "Identification of the type of identifier.",
"isExample": false,
"groupingId": "GroupVS"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/m11-phase-vs"
},
"name": "M11 Phase Value Set",
"description": "Codes drawn from NCI Thesaurus value set $NCIT#C217045 ICH M11 Trial Phase Value Set Terminology\nThese codes represent phases of a study as defined by ICH.",
"isExample": false,
"groupingId": "GroupVS"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/m11-section-codes-vs"
},
"name": "M11 Section Codes Value Set",
"description": "Codes representing sections of M11.",
"isExample": false,
"groupingId": "GroupVS"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/nci-study-role-vs"
},
"name": "NCI Study Role Value Set",
"description": "Codes drawn from NCI Thesaurus as children of $NCIT#C48355 Sponsor\nThese codes represent the roles an individual or an organization can play in a study.\nThere is a value set $NCIT#C215480 - CDISC DDF Study Role Code Value Set Terminology \nbut it does not have any members.",
"isExample": false,
"groupingId": "GroupVS"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/narrative-elements-vs"
},
"name": "Narrative Elements Value Set",
"description": "Composition Types to Manage Protocol Narrative Elements",
"isExample": false,
"groupingId": "GroupVS"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/m11-country-region-vs"
},
"name": "Study Amendment Country Value Set",
"description": "Codes drawn from \nISO 3166 Country Codes, Alpha 3; \nISO 3166 Country Codes, Alpha 2; \nGENC\ncountry affected by an amendment to a study.",
"isExample": false,
"groupingId": "GroupVS"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/m11-amendment-scope-enrollment-vs"
},
"name": "Study Amendment Scope Enrollment Value Set",
"description": "Categorizing numbers affected by the amendment",
"isExample": false,
"groupingId": "GroupVS"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/m11-study-amendment-scope-vs"
},
"name": "Study Amendment Scope Value Set",
"description": "Codes drawn from NCI Thesaurus to represent the scope of an amendment to a study.",
"isExample": false,
"groupingId": "GroupVS"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ResearchStudy"
}
],
"reference": {
"reference": "ResearchStudy/JPMA0001-jpn"
},
"name": "JPMA0001 Provided Example - Japanese Language",
"description": "Illustration of a Japanese language protocol - this is the original Japanese",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile"
],
"groupingId": "GroupJPN"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ResearchStudy"
}
],
"reference": {
"reference": "ResearchStudy/JPMA0001-eng"
},
"name": "JPMA0001 Provided Example - English Language",
"description": "Illustration of a Japanese language protocol - this is the English translation",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile"
],
"groupingId": "GroupJPN"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Group"
}
],
"reference": {
"reference": "Group/JPMA0001-Criteria-JPN"
},
"name": "Japanese Protocol from Vulcan UDP Eligibility Criteria",
"description": "Example showing Janapese text",
"isExample": true,
"groupingId": "GroupJPN"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
}
],
"reference": {
"reference": "Composition/JPMA0001-Section5-jpn"
},
"name": "JPMA0001 Inclusion/Exclusion Narrative",
"description": "Protocol Narrative Sections 5.2 and 5.3",
"isExample": true,
"profile": [
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],
"groupingId": "GroupJPN"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/JPMA-Organization"
},
"name": "JPMA Organization",
"description": "A minimal Organization definition",
"isExample": true,
"groupingId": "GroupJPN"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ResearchStudy"
}
],
"reference": {
"reference": "ResearchStudy/IGBJ-ResearchStudy"
},
"name": "IGBJ Research Study with narrative",
"description": "Illustration of a protocol with some parts in narrative form and some in granular form. The same example can also be viewed\non the server by following this link https://vhewer.com/display-product?url=https://fs-01.azurewebsites.net/Bundle/ICH-M11-Template-IGBJ-Bundle",
"isExample": true,
"profile": [
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],
"groupingId": "GroupIGBJ"
},
{
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{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
}
],
"reference": {
"reference": "Composition/IGBJ-Narrative"
},
"name": "IGBJ Protocol Narrative",
"description": "1.3 Schedule of Activities and 5.1\tDescription of Trial Population and Rationale",
"isExample": true,
"profile": [
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],
"groupingId": "GroupIGBJ"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
}
],
"reference": {
"reference": "Composition/IGBJ-Narrative-1.3"
},
"name": "IGBJ Protocol Narrative 1.3 - Schedule of Activities",
"description": "1.3 Schedule of Activities",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives"
],
"groupingId": "GroupIGBJ"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
}
],
"reference": {
"reference": "Composition/IGBJ-Narrative-2.1"
},
"name": "IGBJ Protocol Narrative 2.1",
"description": "2.1 Purpose of Trial",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives"
],
"groupingId": "GroupIGBJ"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
}
],
"reference": {
"reference": "Composition/IGBJ-Narrative-5.1"
},
"name": "IGBJ Protocol Narrative 5.1",
"description": "5.1\tDescription of Trial Population and Rationale",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives"
],
"groupingId": "GroupIGBJ"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
}
],
"reference": {
"reference": "Composition/IGBJ-Narrative-9"
},
"name": "IGBJ Protocol Narrative 9",
"description": "9\tADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives"
],
"groupingId": "GroupIGBJ"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MedicinalProductDefinition"
}
],
"reference": {
"reference": "MedicinalProductDefinition/IGBJ-MedicinalProduct"
},
"name": "IGBJ Medicinal Product",
"description": "Illustration of a MedicinalProductDefinition used by the protocol",
"isExample": true,
"groupingId": "GroupIGBJ"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
}
],
"reference": {
"reference": "Organization/IGBJ-Organization"
},
"name": "IGBJ Organization",
"description": "A minimal Organization definition",
"isExample": true,
"groupingId": "GroupIGBJ"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Group"
}
],
"reference": {
"reference": "Group/DIBASY-Eligibility"
},
"name": "StudyEligibilityCriteria: Eligibility Criteria for DIBASY Trial",
"description": "Simple Eligibility criteria - Age 30-60 years + BMI>=35 + History type 2 diabetes >5y",
"isExample": true,
"groupingId": "GroupELIG"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Group"
}
],
"reference": {
"reference": "Group/IGBJ-Eligibility"
},
"name": "M11 IGBJ Protocol Example Eligibility Criteria",
"description": "Complex Eligibility Criteria: Multiple criteria",
"isExample": true,
"groupingId": "GroupELIG"
}
],
"page": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "toc.html",
"name": "toc.html",
"title": "Table of Contents",
"generation": "html",
"page": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "index.html",
"name": "index.html",
"title": "Home",
"generation": "html"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "background.html",
"name": "background.html",
"title": "Background",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "best-practice.html",
"name": "best-practice.html",
"title": "Best Practice",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "bundles.html",
"name": "bundles.html",
"title": "Bundles",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "changes.html",
"name": "changes.html",
"title": "Changes",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "credits.html",
"name": "credits.html",
"title": "Credits",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "downloads.html",
"name": "downloads.html",
"title": "Downloads",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "fhir-representation.html",
"name": "fhir-representation.html",
"title": "Fhir Representation",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "info-models.html",
"name": "info-models.html",
"title": "Info Models",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
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